Bowel management system

ABSTRACT

A bowel management system includes a waste collection catheter having at least two distinct sections. The first section is patient proximal when disposed in the patient&#39;s rectum and has durometer hardness in the range of about 50A to about 90A. The second catheter section is connected to the first section and has durometer hardness in the range of about 5A to about 49A. A selectively collapsible, substantially spherical retention balloon is attached coaxially and exterior of the first catheter section such that the proximal-most end of the retention balloon is coincident to the proximal-most end of the first section of the waste collection catheter, the substantially spherical retention balloon having an inflated size so as to be sufficiently large enough to retain the patient proximal end of the catheter in the patient&#39;s rectum without being so large as to trigger a defecatory response in the patient.

REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/413,388, filed Apr. 28, 2006, which is a continuation of U.S. patentapplication Ser. No. 10/225,820, filed Aug. 21, 2002, issued Dec. 12,2006 as U.S. Pat. No. 7,147,627.

FIELD OF THE INVENTION

The present invention relates generally to the field of devices forbowel maintenance, and, more particular, to a rectal catheter havingmultiple sections of varying durometer hardness and a retention balloonto retain the catheter within the rectum of incontinent patients.

BACKGROUND OF INVENTION

Many circumstances can result in an individual becoming incontinent foran extended period of time. Examples of such circumstances include heador spinal cord trauma, disabling strokes, microbial caused illness,broken lower limbs or pelvic bones, digestive disorders, intensive carestays, and as side effects of administration of various pharmaceuticals.Incontinent patients and their caretakers face a great burden in themaintenance of the bowel and its functions. Such patients often sufferfrom constipation, but can also experience boughts of diarrhea, whichimpose even greater nursing problems. Constipation or stool impactioncan be painful and require messy bowel irrigations and/or manualdisimpaction to break up the impacted stool. Diarrhea, on the otherhand, can result in perianal skin breakdown, which in turn can lead toopen wounds and infections. The proper treatment of perianal wounds,whether caused by exposure to feces (i.e. diarrhea) or other etiology,can be especially difficult if the wound is continually beingcontaminated by feces. A great deal of time is necessary to cleansecontaminated wounds, change bedding and treat infections. Thus, there isa great need for devices and methods to improve the function of thebowel in incontinent patients. This need is particularly great inpatients who are incontinent as well as being nonambulatory.

Previously, efforts to address these problems included a variety ofdevices, such as bags or plugs adhered to or inserted into the anus ofnon-ambulatory patients. These methods are limited in theireffectiveness, in part due to leakage around the devices and theresultant effluent that remains in contact with the perianal skin and,in part, due to the complexities of the anal canal anatomy that caninterfere with the use of such devices. Because of the ineffectivenessof the available methods for managing fecal evacuation in bed-riddenpatients, physicians are frequently forced to construct a stoma in thoseindividuals where enough intact perianal skin does not remain or wherethe occurrence of an infection would be life threatening.

Thus, it is among the advantages and features of the present inventionthat it can be used as a bowel maintenance system in a wide variety ofincontinent patients for diversion of fecal matter to a receptacle tominimize contact of such fecal matter with patient skin. The new system(1) facilitates the collection of fecal matter for patients requiringstool management (2) provides access for colonic irrigation and (3)provides a conduit through which medications may be administered.

SUMMARY OF INVENTION

Thus, it was with the above disadvantages and limitations in mind thatthe new bowel management system was developed. The new system iscomposed generally of a rectal catheter having three distinct portions,each with different elasticity and durometer hardness. A retentionballoon mounted on the outer diameter of the patient proximal cathetermaintains the catheter in a position within the rectum that provides foratraumatic sealing and anchoring. An optional intralumenal balloonmounted on the inner diameter of the catheter assists in insertion ofthe device into a patient's rectum and also acts as an anti-reflux valveto obstruct the catheter's evacuation lumen during periods of bowelirrigation or following medication administration for the purpose ofretaining the medications in the patient's rectum. An optional faceplatethat can be anchored to the patient with tape prevents migration of theretention balloon too far into the rectum. A drainage tube extendsoutwardly from the external retention faceplate and functions as aconduit to transport waste and irrigation fluids away from the patientto a waste collection bag. A flush/sampling port is located on thedrainage tube and provides access for catheter flushing (rinsing) andstool sampling.

The catheter of the new system preferably includes three syringeconnectors. One of the connectors is in fluid communication with theretention balloon and one of the connectors is in fluid communicationwith the intralumenal balloon. These connectors facilitate theinflation/deflation of the respective balloons. The third connector isin fluid communication with an optional irrigation lumen that exits thecatheter at the patient proximal tip and is used for bowel irrigationand administration of medication solutions.

Accordingly, in furtherance of the above goals, the present inventionis, briefly, a bowel management system for use in a patient. The newsystem includes a waste collection catheter having at least two distinctsections of varying durometer hardness. A first section, which ispatient proximal and which is disposed in the patient's rectum in normaluse position, has a first end and a second end, and a durometer hardnessin the range of about 50A to about 90A, so that the catheter patientproximal section is stiff enough to automatically maintain an openposition for free flow of bowel waste when in normal use position with aretention balloon inflated. However, the first section is soft andpliable enough to permit folding longitudinally for ease of insertioninto the rectum of the patient. A second section has a first endconnected to the second end of the patient proximal section, and asecond end, and a durometer hardness in the range of about 5A to about49A. The second section can be positioned and retained in the anal canalof the patient for extended periods without distending the sphincters orcausing discomfort. The system also includes a selectively collapsible,substantially spherical retention balloon attached coaxially andexterior of the patient proximal first catheter section such that theproximal-most end of the retention balloon is coincident to theproximal-most first end of the patient proximal first section of thewaste collection catheter. The substantially spherical retention balloonhas an inflated size so as to be sufficiently large enough to retain thepatient proximal end of the catheter in the patient's rectum withoutbeing so large as to trigger a defecatory response in the patient.

The present invention is also, briefly, the combination of a bowelmanagement system for use in a non-ambulatory patient and a wastecollection bag. The bowel management system includes a waste collectioncatheter having at least two distinct sections of varying durometerhardness including a patient proximal first section, which is disposedin the patient's rectum in normal use position, having a first end and asecond end. The durometer hardness of the first section is such that thecatheter patient proximal section is stiff enough to automaticallymaintain an open position for free flow of bowel waste when in normaluse position, yet is soft and pliable enough to permit foldinglongitudinally for ease of insertion into the rectum of a patient. Asecond section has a first end connected to the second end of thepatient proximal first section, and a second end sufficiently spacedfrom the first end that the second section can be positioned andretained in the anal canal of the patient and has a durometer hardnessto permit the retention of the second section in the patient forextended periods without causing discomfort or lesions in the patient. Awaste collection bag is adapted for secure, leak-proof connection to thewaste collection catheter and is sized sufficiently large enough toreceive fecal waste from the patient for extended periods, in the rangeof at least four hours.

The invention is further, briefly, a method for inserting a bowelmanagement system into a patient, the method including:

-   -   (a) providing a bowel management system, the system having:    -   a waste collection catheter having at least two distinct        sections of varying durometer hardness including:    -   a first section which is patient proximal and which is disposed        in the patient's rectum in normal use position, having a first        end and a second end, and a durometer hardness in the range of        about 50A to about 90A, so that the catheter patient proximal        section is stiff enough to automatically maintain an open        position for free flow of bowel waste when in normal use        position with retention balloon inflated, yet is soft and        pliable enough to permit folding longitudinally for ease of        insertion into the rectum of a patient;    -   a second section having a first end connected to the second end        of the patient proximal section, and a second end, and a        durometer hardness in the range of about 5A to about 49A, so        that the second section can be positioned and retained in the        anal canal of the patient for extended periods without        distending the sphincters or causing discomfort; and    -   a selectively collapsible, substantially spherical retention        balloon attached coaxially and exterior of the patient proximal        first catheter section such that the proximal-most end of the        retention balloon is coincident to the proximal-most first end        of the patient proximal first section of the waste collection        catheter, the substantially spherical retention balloon having        an inflated size so as to be sufficiently large enough to retain        the patient proximal end of the catheter in the patient's rectum        without being so large as to trigger a defecatory response in        the patient;    -   (b) folding the patient proximal first end of the waste        collection catheter longitudinally;    -   (c) inserting the folded patient proximal first end of the waste        collection catheter into the patient's rectum sufficiently far        that the selectively collapsible, substantially spherical        retention balloon is entirely within the patient's rectum; and    -   d) securing the waste collection catheter in the position to        which it has been inserted so that the catheter does not become        separated from the patient during an extended period of time, in        the range of hours, while the patient's body waste is permitted        to drain out of the patient's body through the waste collection        catheter.

The invention is further, briefly, a method for inserting a bowelmanagement system into a patient, the method including:

-   -   (a) providing a bowel management system, the system having:    -   a waste collection catheter having at least two distinct        sections of varying durometer hardness including:    -   a first section which is patient proximal and which is disposed        in the patient's rectum in normal use position, having a first        end and a second end, and a durometer hardness in the range of        about 50A to about 90A, so that the catheter patient proximal        section is stiff enough to automatically maintain an open        position for free flow of bowel waste when in normal use        position with retention balloon inflated, yet is soft and        pliable enough to permit folding longitudinally for ease of        insertion into the rectum of a patient;    -   a second section having a first end connected to the second end        of the patient proximal section, and a second end, and a        durometer hardness in the range of about 5A to about 49A, so        that the second section can be positioned and retained in the        anal canal of the patient for extended periods without        distending the sphincters or causing discomfort; and    -   a selectively collapsible, substantially spherical retention        balloon attached coaxially and exterior of the patient proximal        first catheter section such that the proximal-most end of the        retention balloon is coincident to the proximal-most first end        of the patient proximal first section of the waste collection        catheter, the substantially spherical retention balloon having        an inflated size so as to be sufficiently large enough to retain        the patient proximal end of the catheter in the patient's rectum        without being so large as to trigger a defecatory response in        the patient;    -   b) inflating an intralumenal balloon in the patient proximal end        of the waste collection catheter to the extent that the        intralumenal balloon extends slightly beyond the proximal-most        end of the catheter, to thereby provide a curved tip for ease of        introduction of the catheter into the patient's rectum    -   (c) inserting the patient proximal first end of the waste        collection catheter into the patient's rectum sufficiently far        that the selectively collapsible, substantially spherical        retention balloon is entirely within the patient's rectum; and    -   (d) securing the waste collection catheter in the position to        which it has been inserted so that the catheter does not become        separated from the patient during an extended period of time, in        the range of hours, while the patient's body waste is permitted        to drain out of the patient's body through the waste collection        catheter; and    -   (e) deflating the intralumenal balloon in the patient proximal        end of the waste collection catheter to permit free flow of body        wastes from the patient.

These and other objects and advantages will be in part apparent and inpart pointed out herein below.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a schematic perspective view of a bowel management systemconstructed in accordance with and embodying the present invention andshown inflated in the use position.

FIG. 2 is a schematic perspective view of the system of FIG. 1, shownpartially exploded.

FIG. 3 is a schematic representation of the exterior of the rectal tubesubassembly of the system of FIG. 1.

FIG. 3A is an exploded view of the subassembly of FIG. 3.

FIG. 4 is a side elevational view of the drainage tube assembly of FIG.1 with a bag connector attached thereto.

FIG. 5 is an exploded view of FIG. 4.

FIG. 6 is a schematic side view of the patient proximal end of theassembled bowel management system.

FIG. 7 is a longitudinal section, enlarged, through the patient proximalend of the system of FIG. 1 taken on line 7-7 of FIG. 6 and furtherenlarged for clarity of detail.

FIG. 8 is an enlarged schematic elevational view of the rectal tube ofthe assembly of FIG. 1.

FIG. 9 is a longitudinal sectional view taken on line 9-9 of FIG. 8.

FIG. 10 is a transverse sectional view taken on line 10-10 of FIG. 8.

FIG. 11 is an enlarged schematic sectional view of the tri-lumen tube ofthe assembly of FIG. 1.

FIG. 12 is an enlarged partial sectional view showing the lumens, takenfrom FIG. 9.

FIG. 13 is a left end elevational view of FIG. 3, rotated.

FIG. 14 is an enlarged sectional view taken from FIG. 13 showing theconnection of the tri-lumen tube to the rectal tube.

FIG. 15 is a schematic elevational view of a waste collection bag usedwith the system with its various tubes and connectors.

Throughout the drawings like elements are indicated by like elementnumbers.

DETAILED DESCRIPTION

With reference to the figures, and particularly FIGS. 1 and 2, a bowelmanagement system, generally designated 10, includes a catheter 12having a patient proximal end 14 and a patient distal end 16 and threedistinct sections 18, 20, 22 therebetween. Rectal catheter section 18 islocated at the proximal end 14 of the catheter, section 20 is amidsection and section 22 is toward the patient distal end 16. A firstballoon 24, which is inflatable, is mounted at the patient proximal end14 of catheter 12 and a bag connector assembly 26 is mounted at thepatient distal end 16. These elements will be described in furtherdetail hereafter.

Rectal catheter section 18 has a patient proximal opening that, whenpositioned for normal use, opens into the rectum of a patient and asecond end or distal opening which connects to the second cathetersection 20. First catheter section 18 (shown enlarged in FIGS. 8, 9, 10and 12) is formed of a material having a durometer hard enough tomaintain a sufficient opening at the first end of the tube, in order toavoid collapse and subsequent blocking of fecal outflow from thepatient. An example of a suitable material is silicone rubber, 80 SHpolydimethylsiloxane and fumed silica. The optimal durometer range isbetween 50A and 90A shore hardness. The proximal opening must be keptopen, in order to effectively receive stool entering the first cathetersection 18. A relatively large lumen which runs longitudinally withinthe cylindrical wall of tube section 18 is indicated at number 30 inFIGS. 8, 9, 10 and 12. Smaller lumens 32, 34 are located adjacent andparallel to lumen 30 on opposite sides thereof. Reference numeral 36denotes an annular shoulder at the proximal end of catheter section 18.The proximal end of bolster (“retention”) balloon 24 rests againstshoulder 36 when in expanded, inflated use position.

FIGS. 6 and 7 show enlargements of retention balloon 24 mounted to tubesection 18 and show that the proximal end of the balloon 24 is adjacentto and tapers toward the proximal end of tube 18. Retention balloon 24is formed of a selectively collapsible and inflatable material and ismounted coaxially around the proximal end of section 18 so that theextreme ends of each element are substantially flush (or at leastclosely adjacent to) with one another.

FIG. 7 is a longitudinal section of FIG. 6, which illustrates internallyof tube section 18 an optional intralumenal balloon 38 in a collapsedstate. When inflated the intralumenal balloon 38 acts as a anti-reflexvalve (ARV) and if inflated sufficiently so that the patient proximalend of balloon 38 protrudes slightly (as shown in phantom in FIG. 7)beyond the proximal end of tube section 18, the intralumenal balloonalso acts as an aid to insertion of the bowel management assembly intothe patient's rectum. This optional embodiment of the system includes anirrigation lumen 30 (described further herein), which exits the patientproximal end of the catheter section 18 and can be connected to anirrigation supply for inputting irrigant (such as saline) into thepatient's rectum.

FIGS. 3 and 3A illustrate assembled and unassembled, respectively, thesub-assembly of the indwelling portion of the new system 10. From thelower left to the upper right of FIG. 3 there is seen the patientproximal catheter section 18 extending just slightly beyond theretention balloon 24 and then the second catheter section 20. Cathetersection 20 is a cylindrical tube when completely open. It is formed witha very thin wall from a soft elastic material which results in acollapsible tube that when collapsed, such as by the anal sphinctermuscles, creates a very small profile. As this section of the catheteris left in place for very extended periods of time in the patient's analregion this collapsibility is important to prevent loss of the patient'ssphincter tone, as could result over time if a large diameter rigid tubewhere in such place. The optimal durometer range for section 20 isbetween 5A to 49A shore hardness. A first, proximal, end of the secondcatheter section 20 is connected to the distal or second end of thefirst catheter section 18. Catheter section 20 may be constructed as oneunitary tube of singular durometer hardness, thickness and diameter. Anexample of a suitable material for making trans-sphincter cathetersection 20 is silicone rubber, 30 SH polydimethylsiloxane and fumedsilica.

Toward the patient distal end of catheter section 20 there is mounted anoptional faceplate 41 which mounts surrounding the tube 20 and haspreferably at least two sections 42 extending therefrom. Each extension42 can have loops or other connectors 44 thereon to facilitateattachment of the faceplate strap 40 to the patient to keep it in place.Finally, in FIG. 3, at the patient distal end of catheter section 20there is connected an extruded multi-lumen member 46 (shown in enlargedperspective, in FIG. 11) for permitting inflation/deflation of theballoons and flushing of the rectum, if desired. An end view of assembly10 is provided in FIG. 13, showing the relative positions of the strap40 and the multi-lumen catheter. An enlarged sectional view (rotated) inFIG. 14 better illustrates the connection of the multi-lumen member 46with the assembly at catheter section 18. An example of a suitablematerial for forming multi-lumen member 46 is silicone rubber, 57SHpolydimethylsiloxane and fumed silica.

In the exploded view, FIG. 3A, further elements of the subassembly areseen which are hidden or not clear in FIG. 3. This view illustratesretention balloon 24 in its expanded state before application tocatheter section 18. The extensions 24A of the symmetrical balloon oneach end are annular. In FIG. 7 it is seen more clearly how extensions24A are folded under and inwardly so as to seal flat against theexterior wall at opposite ends of catheter section 18.

The figures also show the substantially spherical shape of retentionballoon 24. This shape is important because it seats naturally in thepatient's rectum to prevent leaking around the retention balloon. Theshape of the balloon is important to prevent damage to the rectal walland to achieve optimum sealing to prevent leakage and to effectivelyfunnel fecal matter into the proximal opening of catheter section 18.Thus, the shape needs to be substantially spherical, not elliptical ortorrodial.

The size of the balloon when inflated is not only critical to preventleakage but also to prevent migration of the new system 10 out of therectum. The optimal size for balloon 24 for the normal adult patient isbetween 44 cc and 69 cc. It has been shown in the literature that avolume of 90 cc is sufficient to trigger a defecatory response and thusthe retention balloon should not be sized to reach this volume. Theminimum of 44 cc is critical in order to prevent leakage and outwardmigration from the rectum of the patient. The size of the balloon asexpressed by a length to diameter ratio is 0.75 at the low end of theinflation range, 44 cc, (i.e., the balloon length is 1.35 inches and theballoon diameter would then be 1.8 inches) and 0.61 at the upper end, 69cc (i.e., a balloon length of 1.35 inches and a balloon diameter of 2.32inches). It is to be understood that all sizes given herein are for anaverage adult patient and can be adjusted proportionally for othernon-average patients. The retention balloon 24 is inflated via a lumen34, which opens into the balloon. The lumen is connected via amulti-lumen member 46 to an inflation device, such as a syringe, filledwith air or saline or some other biocompatible fluid. The inflationdevice limits the volume of inflation medium infused to a volume thatresults in the inflation of the balloon to the desired range of 44 to 69cc.

An example of a suitable material from which to form retention balloon24, in order to achieve the desired results is silicone rubber, 30SHpolydimethylsiloxane and fumed silica. Alternatively, the retentionballoon material itself could limit the size if a material or structurewas used that would only expand to the optimum size. An example of suchmaterial would be polyimide. An example of such a structure would be astiff mesh impregnated into an otherwise elastic material such assilicone that would mechanically limit the retention balloon size wheninflated. In turning to FIG. 3A, to the right of the retention balloon24 is shown a second balloon 38 which is illustrated in its collapsedposition. Balloon 38 is also illustrated in FIG. 7 collapsed in solidlines and inflated in broken lines. When inflated, balloon 38 fills thelumen of catheter section 18 to block reflux and facilitates insertionof the system into a patient.

Further with reference to FIG. 3A, catheter section 18 is shown then tothe right of balloon 38. To the right of catheter section 18 are showntwo small TEFLON tubes 48 which interconnect paired small lumen in themulti-lumen catheter 46 to corresponding openings to paired lumen inrectal catheter section 18. An optional radiopaque marker 50 ispreferably annular and is useful for accurately determining the locationof and position of the assembly portion within the rectum of thepatient. Marker 50 is formed for example of material such as a tungstensilicone mixture, which is biocompatible, but easily detected byradiograph. To the right of radiopaque marker 50 in FIG. 3A is shown thetrans-sphincter catheter section 20, the midsection of catheter 12.FIGS. 3 and 3A also illustrate the positioning of the faceplate 40 as itis mounted by a through hole onto the patient distal end of mid-cathetersection 20. A bridge section or drain tube connector band 52 isillustrated to the right of element 40 in FIG. 3A and also is visible inFIG. 3. Bridge section 52 permits the third, patient distal segment ofcatheter 12, segment 22 to be connected in abutting relationship withmidsection 20, by a slip fit of the sections 20, 22 over (or optionally,under) the segment 52. Extruded multi-lumen member 46 is illustrated atthe right of FIG. 3A and is shown in part, enlarged in FIG. 11 forclarity. In this embodiment, the multi-lumen member 46 is relativelyflat and elongated and bears a large central lumen 30 flanked by twosmaller lumen 32, 34 on opposite sides of lumen 30, as previouslydiscussed.

FIGS. 1 and 2 illustrate three ports (for example, luer-styleconnectors), which are connectable to the various lumens in multi-lumenmember 46. The larger central port 54 attaches to large lumen 30 a inthe multi-lumen member and is used for connection of a syringe or otherinfusion device in order to infuse irrigants or medications. An optionalport 56 connects to one of the small optional lumens (e.g., 32 a) in themulti-lumen member 46 for inflation and deflation of the optionalintralumenal balloon 38 with a syringe or other appropriate device. Theother small optional port 58 connects to small lumen 34 a, in themulti-lumen member 46 in order to inflate and deflate the retentionballoon with a syringe or other appropriate device.

FIGS. 4 and 5 illustrate the subassembly of the third catheter segment22. Segment 22 connects at a patient proximal end 22 a to the distal endof the trans-sphincter mid-segment 20 and the opposite, patient distalend 22 b to a connector 66, which is adapted for connection to acollection bag for example as illustrated at 60 in FIG. 15. The thirdcatheter section 22 is formed of a non-collapsible tube constructed of amaterial that is stiff enough to maintain its shape to minimize kinkingand facilitate drainage of the tube, but soft enough to be “milked” by acare professional to force through fecal material. Optional applicationof a coating to the exterior of section 22 can facilitate milkingthereof and optional internal coating of section 22 facilitatesflow-through of feces by decreasing friction against the internal sidewall.

Catheter 22 as shown has an optional sampling/flushing port 62 (shownmost clearly in FIG. 5) to provide access to the lumen of section 22 fortaking fecal samples or for flushing to clean the catheter. In order toprevent bacterial contamination of the catheter and to also aid inreduction of odor to fecal build up in the catheter, frequent flushingthrough the optional sampling/flushing port 62 is preferred. A cover forport 62, 63 of any suitable variety is also desirable.

The connector assembly 66 illustrated at end 22 b of catheter 22includes a sleeve 64 spacedly along the length of catheter 22 to receiveand retain the connector assembly, which attaches 22 b to collection bag60. It may be a heat-shrinkable band or other suitable retention meansas desired. As shown in FIG. 5 connector assembly 66 fits into the end22 b and then is adapted, also with an optional O-ring (e.g. 67), toconnect in a sealing manner to the bag. A closure portion 68 is alsodesirable for closing off the connector assembly 66 preventing leakagewhen the bag is separated from catheter portion 22. If desired, theclosure portion 68 may be connected by a string, strip, cord or otherpiece 70 to end 26.

System 10 catheter section 22 empties into a collection bag 60, whichcan be hung by the bedside to collect fecal waste matter. FIG. 15illustrates waste collection bag 60, which is considerably larger thanwhat would ordinarily be used for a colostomy or urinary bag and the bagmay be left in place for long periods of time without having to beemptied. It is expected that bag 60 will have approximately a threeliter capacity, and be provided with a hook 72 for hanging on the bed orchair and of course a connector 73 for connection to the catheterconnector assembly 66 in a sealing manner. The waste bag 60 alsooptionally carries a drain tube holster 74, such as the U-shapedconnector illustrated, for example, and a clamp 76 for sealing off thecollection bag drain tube 82. Clamp 76 desirably carries a button 78 orother connector, which slips into holster 74 or otherwise attaches tobag 60. Closure portion 75 is also desirable for preventing leakage fromthe bag connector 73 when the bag is not connected to the catheterportion 22 of the bowel management system 10. An outlet tube 82 is alsoprovided for draining out the contents of the bag. It is preferred thatthe bag 60 be suitable for folding up because it is rather long; inorder to prevent it from dragging on the floor. Clamp 76 carrying thebutton holster connector 78 is useful for sealing off collection bagdrain tube 82 by pinching it. Also, Cap 80, which is preferably attachedto the holster 74 is useful for blocking the open tip (not shown) of bagdrain tube 82.

Another optional feature of the new bowel management system is theprovision of a faceplate which would serve as a retention mechanism toprevent internal migration of the bowel management system 10, as well asto prevent rotation of the trans-sphincter catheter section 20 of thedevice. Such a faceplate 41 can be mounted on the bridge section 52 asillustrated, in FIGS. 1 and 2, as one useful example. The faceplate cantake the form of a strap, wedge, donut, etc. and would preferably bemade of silicone, foam or other soft material to avoid irritation of thepatient's skin.

FIGS. 1 and 2 also illustrate a clip assembly 21 for attachment of theassembly 10 to a sheet, bedclothes, etc. It is to be understood that theillustrated embodiment is merely one useful assembly for accomplishingthis task. As shown, an elastomeric band surrounds a simple pinch clipfor gripping fabric or other thin material for the purpose of holdingthe assembly in position.

Other useful stabilizing devices are conceived.

Use of the New Bowel Management System:

For insertion of bowel management system 10 into a non-ambulatorypatient it is preferred that the patient be in the left side downposition, if possible, although other positions may be utilized ifnecessary due to the patient's clinical condition. The procedure forinsertion is performed using recognized aseptic techniques asappropriate.

A device is selected with the appropriate trans-sphincter cathetersection length, usually 4 cm for a female patient, or 6 cm for a malepatient. And the rectum of the patient is examined to confirm no rectalimpaction and to be sure that no lesions or strictures exist which wouldpreclude use of the device. A 60 cc syringe is filled with 35 cc 40 ccwater and a 30 cc syringe is filled with 20 cc water. The 30 cc syringeis attached to the intralumenal balloon connector and the intralumenalballoon 38 is filled with the 20 cc's of fluid.

Lubricant is applied to patient proximal end of the device including theprotruding intralumenal balloon 38, the deflated retention balloon 24and the patient's anus. Using the protruding end of the intralumenalballoon as an introducer, the patient proximal end of catheter section18 is guided through the anus and into the distal rectum.

The 60 cc syringe is attached to the retention balloon connector 58 andthe retention balloon 24 is inflated with the syringe contents (in thisexample, 35 cc 40 cc water). The catheter connector assembly 66 isconnected to the waste collection bag connector 73 and bag 60 ispositioned at bedside so that the catheter drainage tube 22 is nottwisted or kinked. This allows for unobstructed fecal matter flow fromthe catheter 22 into bag 60.

After the catheter system is inserted into the patient's rectum andconnected to the drainage bag, the 30 cc syringe is used to completelyaspirate the 20 cc of water (or air) from intralumenal balloon 38. The30 cc syringe is disconnected from the intralumenal balloon connector.

Catheter/bowel lumenal patency is confirmed by performing the followingprocedure:

The patient is placed in a slight head up position to promote drainage,the gravity irrigation or enteral feeding bag is filled with one literof warm tap water and hung from an IV pole two to three feed above theheight of patient's anus. The irrigation bag administration set isconnected to the catheter irrigation port 54. After the caretakerverifies the connection to the correct catheter port, gravity irrigationis begun. Large stool pieces are broken up by a combination ofirrigating and manual douching (i.e. constricting outflow and squeezingthe drainage tube repeatedly). Irrigation is discontinued when stoolpieces are no longer present in the effluent.

Irrigation of the patient's rectum can be performed using a gravity bagor by using a syringe. In the gravity bag method it is necessary toprovide a waste collection bag with at least two liters of availablevolume. A standard gravity irrigation or enteral feeding bag withpre-attached administration set is used to infuse about a liter of warmtap water into the patient's anus at a flow rate of about one liter insix to ten minutes. The irrigation bag administration set is connectedto the catheter system irrigation port and the 30 cc syringe (filledwith 20 cc of fluid) is attached to the intralumenal balloon connectorand the intralumenal balloon 38 is filled with the 20 cc's of fluid.

With the patient in a slight head down position the flow control valveon the irrigation bag set is opened and fluid is allowed to drain bygravity into the rectum and colon. If leakage occurs past the retentionballoon during irrigation more water is injected into the retentionballoon up to a maximum inflation volume of 50 cc.

The infused irrigant is permitted to remain as long as prescribed byphysician. Then the 20 cc volume of fluid with which the intralumenalballoon was inflated is removed via syringe and the mixed fluid andfeces are allowed to drain out of the rectum and colon. If necessary,the patient's position is modified to slight head up. Once irrigation iscomplete the administration set is disconnected from the catheterirrigation port. Any additional fluid that was injected into theretention balloon is removed by syringe via the retention balloonconnector. If necessary the retention balloon may be completelyaspirated and refilled to normal use volume (about 35 to about 40 cc).

If irrigation is performed using a syringe instead of a gravity bagpreparations are similar, ensuring that sufficient space is available inthe waste collection bag, and then a syringe is prepared with about 60cc of warm tap water. A 30 cc syringe is prepared with about 20 cc ofair or water and attached to the intralumenal balloon connector and theintralumenal balloon is inflated. The syringe is connected to thecatheter irrigation port. With the patient in a slight head downposition the irrigant is slowly injected into the rectum and colon. Aswith the gravity bag irrigation method, any leakage can be handled byfurther inflating the retention balloon. Similarly, irrigant ispermitted to dwell for a prescribed time and then the fluid is aspiratedfrom the intralumenal balloon with a syringe to allow drainage of fluidand feces out of the rectum and colon. If necessary the patient'sposition can be modified. Again, if extra fluid was introduced into theretention balloon it can now be released and the waste bag emptied ifnecessary.

The system irrigation port can be useful for administering medicationsor enema solutions. In this case, the port is preferably flushed firstwith about 10 cc to about 20 cc of water before and after administrationof enema/medication solution. A syringe is filled with the desiredsolution to be introduced and a 30 cc syringe is filled with about 20 ccof air or water. After inflating the intralumenal balloon, the solutionis injected and the catheter irrigation lumen is flushed as indicated.The syringe is then disconnected from the irrigation port and thesolution is permitted to dwell for the prescribed time. The intralumenalballoon is then deflated, preferably by use of a 30 cc syringe, aspreviously described.

The flush/sampling port of the system can also be used to draw samplesof fecal mater by use of a catheter tip syringe attached to theflush/sampling port. This can be very useful for monitoring a patient'sprogress and for testing purposes.

In view of the foregoing, it will be seen that the several objects ofthe invention are achieved and other advantages are attained. Althoughthe foregoing includes a description of the best mode contemplated forcarrying out the invention various modification s are conceivable.

As various modifications could be made in the constructions hereindescribed and illustrated without departing from the scope of theinvention it is intended that all matter contained in the foregoingdescription or shown in the accompanying drawings shall be interpretedas illustrative rather than limiting.

1-42. (canceled)
 43. A bowel management system for use in a patientcomprising: a waste collection catheter including: a first section whichis patient proximal and which is disposed in the patient's rectum innormal use position, having a first end and a second end, and adurometer hardness in the range of about 50A to about 90A, so that thecatheter patient proximal section is stiff enough to automaticallymaintain an open position for free flow of bowel waste when in normaluse position with a retention balloon inflated, yet is soft and pliableenough to permit folding longitudinally for ease of insertion into therectum of a patient; a second section having a first end connected tothe second end of the patient proximal section, and a second end, and adurometer hardness in the range of about 5A to about 49A, so that thesecond section can be positioned and retained in the anal canal of thepatient for extended periods without distending the sphincters orcausing discomfort; and a selectively collapsible retention balloonattached coaxially and exterior of the patient proximal first cathetersection such that the proximal-most end of the retention balloon iscoincident to the proximal-most first end of the patient proximal firstsection of the waste collection catheter, the retention balloon havingan inflated size so as to be sufficiently large enough to retain thepatient proximal end of the catheter in the patient's rectum withoutbeing so large as to trigger a defecatory response in the patient. 44.The system of claim 43, and further comprising a lumened member which issubstantially smaller in diameter than the waste collection catheter andwhich has a first end and a second end, the first end of the lumenedmember being connected to the patient proximal first section of thewaste collection catheter and being in fluid communication with theselectively collapsible retention balloon, and wherein the second end ofthe lumened member is connectable to a port for introduction or removalof fluid from the retention balloon, for selective inflation anddeflation of the retention balloon as necessary for insertion, retentionor removal of the rectal catheter patient proximal segment to or fromthe patient's rectum.
 45. The system of claim 44, wherein the lumenedmember has at least two independent lumens, each of the lumens beingconnectable at the second end of the lumened member to a port forintroduction or removal of fluid from the system, one of the two lumensbeing in fluid communication with the first end of the patient proximalsegment of the waste collection catheter, to thereby permit introductionof treatment substances to the patient's rectum.
 46. The system of claim43, wherein the retention balloon has an inflated length-to-diameterratio in the range of about 0.75 to about 0.61, with a volume of about44 cc to about 69 cc.
 47. The system of claim 43, and further comprisingan intralumenal balloon mounted to an interior of the patient proximalfirst segment of the waste collection catheter.
 48. The system of claim47, wherein the intralumenal balloon is in fluid communication with alumen of the lumened member to thereby permit selective inflation anddeflation of the intralumenal balloon and to function as an anti-re fluxdevice.
 49. The system of claim 47, and further comprising anintralumenal balloon mounted to the patient proximal end of the wastecollection catheter, wherein the lumened member has a first lumen, asecond lumen and a third lumen, the first lumen being in fluidcommunication with the selectively collapsible retention balloon tothereby permit selective inflation and collapse the retention balloon asnecessary for insertion, retention or removal of the rectal catheterpatient proximal first segment to or from the patient's rectum, thesecond lumen being in fluid communication with the inside of the patientproximal first segment of the waste collection catheter, to therebypermit introduction of substances to the patient's rectum, and the thirdlumen being in fluid communication with the intralumenal balloon. 50.The system of claim 43, and further comprising a third section of thewaste collection catheter, which is positioned patient distal in normaluse.
 51. The system of claim 50, wherein the third section of the wastecollection catheter is coated internally with a substance to facilitateflow-through of waste matter from the patient.
 52. The system of claim50, wherein the patient distal third section of the waste collectioncatheter is coated externally with a substance to facilitate “milking”of the waste collection catheter by a caretaker for the patient.
 53. Thesystem of claim 50, and further comprising a selectively openable andcloseable access port in the patient distal third segment of the wastecollection catheter to thereby permit access to the internal catheterfor sampling and insertion of medication and fluids.
 54. The system ofclaim 43, and further comprising at least one flexible strip connectedadjacent to the second end of the second section of the waste collectioncatheter, to thereby provide optional means by which to releasablyattach the waste collection catheter to the non-ambulatory patient tostabilize and secure the system in use position.
 55. The system of claim43, and further comprising a face plate of soft, pliable material, thefaceplate being disposed adjacent to the second end of the secondsection of the waste collection catheter to thereby provide stability tothe system in use position.
 56. The system of claim 50, and furthercomprising a closure member connectable to the second end of the patientdistal third segment of the waste collection catheter.
 57. The system ofclaim 50, and further comprising a sleeve disposed about the thirdcatheter section.
 58. The system of claim 57, and further comprising aconnector assembly in communication with a distal end of the thirdcatheter section, wherein the connector assembly is received andretained by the sleeve.
 59. The system of claim 58, wherein a proximalportion of the connector assembly fits in the distal end of the thirdcatheter section.
 60. The system of claim 59, wherein the sleeve is ashrinkable band that secures the distal end of the third cathetersection about the proximal portion of the connector assembly.
 61. Thesystem of claim 50, and further comprising a connector assembly incommunication with a distal end of the third catheter section, wherein aproximal end of the connector assembly fits in a distal end of the thirdcatheter section.
 62. A method for inserting a bowel management systeminto a patient, the method comprising: (a) providing a bowel managementsystem, the system having a waste collection catheter including: a firstsection which is patient proximal and which is disposed in the patient'srectum in normal use position, having a first end and a second end, anda durometer hardness in the range of about 50A to about 90A, so that thecatheter patient proximal section is stiff enough to automaticallymaintain an open position for free flow of bowel waste when in normaluse position with retention balloon inflated, yet is soft and pliableenough to permit folding longitudinally for ease of insertion into therectum of a patient; a second section having a first end connected tothe second end of the patient proximal section, and a second end, and adurometer hardness in the range of about 5A to about 49A, so that thesecond section can be positioned and retained in the anal canal of thepatient for extended periods without distending the sphincters orcausing discomfort; and a selectively collapsible retention balloonattached coaxially and exterior of the patient proximal first cathetersection such that the proximal-most end of the retention balloon iscoincident to the proximal-most first end of the patient proximal firstsection of the waste collection catheter, the retention balloon havingan inflated size so as to be sufficiently large enough to retain thepatient proximal end of the catheter in the patient's rectum withoutbeing so large as to trigger a defecatory response in the patient; (b)folding the patient proximal first end of the waste collection catheterlongitudinally; (c) inserting the folded patient proximal first end ofthe waste collection catheter into the patient's rectum sufficiently farthat the selectively collapsible retention balloon is entirely withinthe patient's rectum; and d) securing the waste collection catheter inthe position to which it has been inserted so that the catheter does notbecome separated from the patient during an extended period of time, inthe range of hours, while the patient's body waste is permitted to drainout of the patient's body through the waste collection catheter.
 63. Themethod of claim 62, wherein securing the waste collection catheter inthe position to which it has been inserted includes the step ofinflating the retention balloon so that the ratio of balloonlength-to-diameter is in the range of about 0.75 to about 0.61.
 64. Themethod of claim 62, and further comprising irrigating the patient'sbowel by providing an intralumenal balloon mounted to the patientproximal end of the waste collection catheter and a lumened member,wherein the lumened member has a first lumen, a second lumen and a thirdlumen, the first lumen being in fluid communication with the selectivelycollapsible retention balloon to thereby permit selective inflation andcollapse the retention balloon as necessary for insertion, retention orremoval of the rectal catheter patient proximal first segment to or fromthe patient's rectum, the second lumen being in fluid communication withthe inside of the patient proximal first segment of the waste collectioncatheter, to thereby permit introduction of substances to the patient'srectum, and the third lumen being in fluid communication with theintralumenal balloon; providing a further section to the wastecollection catheter, the further section having a port therein; infusingsufficiently large volumes of fluid into the system to permit irrigationof the patient's bowel and rinsing of the catheter from time to time, asnecessary; inflating the intralumenal balloon to retain the fluid withinthe patient's bowel, and after a predetermined interval; releasing theirrigation fluid by deflating the intralumenal balloon and permittingthe fluid to flow through the waste collection catheter into a wastecollection vessel.
 65. A bowel management system for use in a patientcomprising a waste collection catheter including: a first section whichis patient proximal and which is disposed in the patient's rectum innormal use position, having a first end and a second end, and adurometer hardness in the range of about 50A to about 90A, so that thecatheter patient proximal section is stiff enough to automaticallymaintain an open position for free flow of bowel waste when in normaluse position with a retention balloon inflated, yet is soft and pliableenough to permit folding longitudinally for ease of insertion into therectum of the patient; a second section having a first end connected tothe second end of the patient proximal section, and a second end, and adurometer hardness in the range of about 5A to about 49A, so that thesecond section can be positioned and retained in the anal canal of thepatient for extended periods without distending the sphincters orcausing discomfort; and a selectively collapsible retention balloonattached coaxially and exterior of the patient proximal first cathetersection such that the proximal-most end of the retention balloon iscoincident to the proximal-most first end of the patient proximal firstsection of the waste collection catheter, the retention balloon havingan inflated size so as to be sufficiently large enough to retain thepatient proximal end of the catheter in the patient's rectum withoutbeing so large as to trigger a defecatory response in the patient, andfurther comprising a lumened member which is substantially smaller indiameter than the waste collection catheter and which has a first endand a second end, the first end of the lumened member being connected tothe patient proximal first section of the waste collection catheter andbeing in fluid communication with the selectively collapsible retentionballoon, and wherein the second end of the lumened member is connectableto a port for introduction or removal of fluid from the retentionballoon, for selective inflation and deflation of the retention balloonas necessary for insertion, retention or removal of the rectal catheterpatient proximal segment to or from the patient's rectum.
 66. A wastecollection catheter having at least two sections for receiving, carryingand removing bowel waste from a patient, comprising: a rectal cathetersection having a patient proximal opening that, when in a position fornormal use, opens into a patient's rectum to receive bowel waste, therectal catheter section being sufficiently pliable to permit folding forease of insertion into a patient's rectum while also being sufficientlystiff following insertion to maintain an open position in a patient'srectum for free flow of bowel waste through the patient proximalopening; a trans-sphincter catheter section distal to the rectalcatheter section that can be collapsed by a patient's anal sphinctermuscles when in a position for normal use; the trans-sphincter cathetersection being sufficiently soft to be retained in a patient's anal canalfor extended periods, without distending a patient's anal sphinctermuscles or otherwise causing discomfort, and extending from internallyof a patient, through the anal sphincter muscles, to externally of apatient; a third catheter section extending from a distal end of thetrans-sphincter catheter section and which is positioned patient distalin normal use; an inflatable balloon extending radially outwardly of thepatient proximal opening for retaining the patient proximal opening in aposition for normal use in an open position for flow of bowel wastethrough the patient proximal opening; and a connector assembly incommunication with a distal end of the third catheter section, wherein aproximal end of the connector assembly fits in a distal end of the thirdcatheter section.
 67. The waste collection catheter of claim 66, andfurther comprising a sleeve disposed about the third catheter section.68. The waste collection catheter of claim 67, wherein the connectorassembly is received and retained by the sleeve.
 69. The wastecollection catheter of claim 67, wherein the sleeve is a shrinkable bandthat secures the distal end of the third catheter section about theproximal portion of the connector assembly.
 70. The waste collectioncatheter of claim 66, further comprising an annular shoulder at aproximal end of the rectal catheter section.
 71. The waste collectioncatheter of claim 70, wherein a proximal end of the inflatable balloonrests against the annular shoulder when the inflatable balloon isinflated.
 72. The waste collection catheter of claim 66, furthercomprising a closure portion for selectively closing off the distal endof the third catheter section.
 73. The waste collection catheter ofclaim 72, wherein the closure portion is connected to the third cathetersection by one of a string, a strip, or a cord.
 74. A waste collectioncatheter having at least two sections for receiving, carrying andremoving bowel waste from a patient, comprising: a rectal cathetersection having a patient proximal opening that, when in a position fornormal use, opens into a patient's rectum to receive bowel waste, therectal catheter section being sufficiently pliable to permit folding forcase of insertion into a patient's rectum while also being sufficientlystiff following insertion to maintain an open position in a patient'srectum for free flow of bowel waste through the patient proximalopening; a trans-sphincter catheter section distal to the rectalcatheter section that can be collapsed by a patient's anal sphinctermuscles when in a position for normal use; the trans-sphincter cathetersection being sufficiently soft to be retained in a patient's anal canalfor extended periods, without distending a patient's anal sphinctermuscles or otherwise causing discomfort, and extending from internallyof a patient, through the anal sphincter muscles, to externally of apatient; a third catheter section extending from a distal end of thetrans-sphincter catheter section and which is positioned patient distalin normal use; an inflatable balloon extending radially outwardly of thepatient proximal opening for retaining the patient proximal opening in aposition for normal use in an open position for flow of bowel wastethrough the patient proximal opening; a connector assembly incommunication with a distal end of the third catheter section; and aclosure portion for selectively closing off the distal end of the thirdcatheter section.